The Role of Probiotics PS128 in Movement Disorders

Phase

N/A

Condition

Tic Disorders

Autism

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT03259971

201703061MIPA

Ages 1-50
All Genders

Study Summary

Pediatric movement disorders comprise of a large number of different neurological diseases including Rett syndrome (RTT) and Tourette syndrome. Studies in the literature as well as our preliminary reports showed that Rett syndrome and Tourette syndrome/Tic disorders are associated with a dysbiosis of the gut microbiota compared to normal control. Probiotic Lactobacillus plantarum PS128 is a diet supplement that available for human consumption. Probiotic Lactobacillus plantarum PS128 had showed psychotropic effects such as ameliorate anxiety- and depression-like behaviors as well as altered the level of neurotransmitters such as dopamine in the brain in animal models, which might be through microbiota-gut-brain axis. Therefore, the purpose of this study is to access the possible neurobehavior effects of Probiotic Lactobacillus plantarum PS128 in Rett syndrome and Tic disorders/Tourette syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Rett syndrome:
Males and females who have classic or atypical RTT diagnosed under consensus criteria
Age: 1-50 years
Tic disorders:
males and females with clinical diagnosis
Age: 8-18years
Treatment naive 4 weeks prior to study
Those with standard medications, dosage stable 4 weeks prior to study
AADC syndrome:
Males and females with AADC diagnosis
Age: 1-50 years

Exclusion

Exclusion Criteria:

Those who took probiotic or probiotic related product 4 weeks prior to the study orduring the study
Those who took antibiotic 4 weeks prior to the study
Those showing poor compliance with any aspect of the study
Those had adverse reactions to PS128

Study Design

August 25, 2017

August 20, 2021

Study Description

The study is a placebo-controlled double-blind randomized study, to determine the benefits of probiotic Lactobacillus plantarum PS128 vs placebo on symptoms for Tic disorders; and the symptoms, behavior, or cognition for Rett syndrome.

Patients with the Rett syndrome and Tic disorders/Tourette syndrome will be recruited into our study.The study period will last 4 months for Rett syndrome patients, age one year-50years; while 2 months for Tic disorders/Tourette syndrome patient, age 5 years-18 years.

The study will be performed in National Taiwan University Children Hospital. The patients will have neuropsychological and gut microbiota evaluation before and at the end of the study. There will also be interim follow up evaluations each month after the patient start taking the probiotic or placebo.

Connect with a study center

National Taiwan University Children Hospital
Taipei, 100
Taiwan
Active - Recruiting

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